FDA Approves At-Home Leqembi autoinjector for Alzheimer’s Disease
The FDA has approved a new subcutaneous autoinjector (SC-AI) formulation for lecanemab (Leqembi; Eisai), a therapy for patients with early-stage Alzheimer disease (AD) and mild cognitive impairment (MCI) due to AD. This marks the first at-home, self-administered option for ongoing AD treatment in the United States, increasing convenience and access for patients.1
Data from the phase 3 Clarity AD trial (NCT03887455) supported the approval. The SC-AI offers quicker administration-approximately 15 seconds. Clinical trials demonstrated comparable drug exposure, improved tolerability, enhanced amyloid clearance, and positive feedback from patients, caregivers, and healthcare professionals. It’s expected to lower treatment and administration costs, resulting in meaningful societal savings.
Branded as Leqembi Iqlik (pronounced “I click“), the autoinjector delivers 360 mg/1.8 mL (200 mg/mL) over about 15 seconds.It’s indicated for maintenance dosing in patients with MCI or mild dementia from AD. After an 18-month course of lecanemab-irmb IV treatment at 10 mg/kg every 2 weeks, patients can switch to weekly 360-mg subcutaneous injections with the autoinjector or continue with infusions at 10 mg/kg every 4 weeks.
The Clarity AD trial, published in the New England Journal of Medicine, followed 1795 patients with confirmed amyloid pathology for 18 months of lecanemab treatment.2 A subsequent analysis, lead by Reisa Sperling, MD, of Brigham and Women’s Hospital, specifically examined outcomes with the SC-AI formulation.
Results showed that after 6 months, patients receiving SC-AI achieved comparable amyloid reduction to those receiving IV infusions. The SC-AI also maintained a favorable safety profile.
References
- Eisai. FDA Approves LEQEMBI® (lecanemab-irmb) Subcutaneous Autoinjector for the Treatment of Early Alzheimer’s Disease. Published August 26, 2024. Accessed August 29,2024.
- Sperling RA, et al. Efficacy and Safety of Subcutaneous Lecanemab in Early Alzheimer’s Disease. New England Journal of Medicine. Published November 29, 2023. Accessed August 29, 2024.